510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821503Substantially Equivalent

Iris Urine Stain

Intl. Remote Imaging Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821503 is the FDA 510(k) clearance record for IRIS URINE STAIN, a class I device, cleared for Intl. Remote Imaging Systems on under FDA product code ICF (Crystal Violet For Histology). FDA records list 14 510(k) clearances for Intl. Remote Imaging Systems, from to . As of , FDA records show no recalls naming K821503.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ICF Crystal Violet For Histology
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Intl. Remote Imaging Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ICF

Trailing 12 months

FDA records hold no clearances under product code ICF in the trailing twelve months.

FDA records show no clearances under product code ICF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ICF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260